| 510(k) Number |
K912189 |
| Device Name |
LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION |
| Applicant |
| Physio-Control Corp. |
| 11811 Willows Rd., NE |
| P.O. Box 97006 |
|
Redmond,
WA
98073
|
|
| Applicant Contact |
SHERRI L POCOCK |
| Correspondent |
| Physio-Control Corp. |
| 11811 Willows Rd., NE |
| P.O. Box 97006 |
|
Redmond,
WA
98073
|
|
| Correspondent Contact |
SHERRI L POCOCK |
| Classification Product Code |
|
| Date Received | 05/17/1991 |
| Decision Date | 02/14/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|